US2025368611A1PendingUtilityA1

Method for preparing beraprost 314-d sodium

Assignee: YS LIFE SCIENCE CO LTDPriority: May 30, 2024Filed: May 29, 2025Published: Dec 4, 2025
Est. expiryMay 30, 2044(~17.8 yrs left)· nominal 20-yr term from priority
C07C 67/317C07C 67/31C07C 68/02C07C 2601/10C07D 307/93A61P 29/00A61P 37/06A61K 31/343C07C 67/30C07C 69/734C07C 67/32
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Claims

Abstract

The present disclosure provides methods of synthesizing a compound of Formula I. The method proceeds through several different pathways including a radical cyclization. Also disclosed are compositions the compound of Formula I as well as methods of using the compound of Formula I in the treatment several conditions or disorders.

Claims

exact text as granted — not AI-modified
1 . A method of preparing a product comprising a compound of Formula I having the structure: 
       
         
           
           
               
               
           
         
         wherein 
         R 1  is selected from H and a cation; 
         R 2  and R 3  are independently C 1-6  alkyl; 
         the method comprising the steps of: 
         (a) performing a condensation reaction on the compound 
       
       
         
           
           
               
               
           
         
       
       to form the compound 
       
         
           
           
               
               
           
         
       
       wherein R 4  is C(O)C 1-6  alkyl and R 5  is C 1-6  alkyl;
 (b) coupling the carbonate of CPD-02 with 
 
       
         
           
           
               
               
           
         
       
       to form the compound 
       
         
           
           
               
               
           
         
       
       wherein is R 6  is C 1-6  alkyl and X is halide;
 (c) hydrolyzing CPD-04 to form the compound 
 
       
         
           
           
               
               
           
         
         (d) protecting the alcohol of CPD-05 to form the compound 
       
       
         
           
           
               
               
           
         
       
       wherein R 7  is a hydroxy protecting group;
 (e) performing a radical cyclization and trapping reaction on CPD-06 with 
 
       
         
           
           
               
               
           
         
       
       to form the compound 
       
         
           
           
               
               
           
         
       
       wherein R 8  and R 9  are independently C 1-6  alkyl; and
 (f) converting CPD-08 to a compound of Formula I; 
 wherein the compound of Formula I is at least about 90% pure; 
 wherein the total amount of the impurities is in an amount of less than about 10.0%; and 
 wherein any individual impurity is present in an amount of less than about 1.0%. 
 
     
     
         2 . The method of  claim 1 , further comprising cleaving the double bond of CPD-08 to from the compound 
       
         
           
           
               
               
           
         
       
     
     
         3 . The method of  claim 2 , further comprising coupling CPD-09 with 
       
         
           
           
               
               
           
         
       
       to form the compound 
       
         
           
           
               
               
           
         
       
     
     
         4 . The method of  claim 3 , further comprising reduction of the ketone of CPD-11 to form the compound 
       
         
           
           
               
               
           
         
       
     
     
         5 . The method of  claim 4 , further comprising the deprotection of CPD-12 to form the compound 
       
         
           
           
               
               
           
         
       
     
     
         6 . The method of  claim 5 , further comprising hydrolyzing CPD-12 to form the compound Formula I. 
     
     
         7 . The method of  claim 1 , wherein R 1  is Na + . 
     
     
         8 . The method of  claim 1 , wherein R 2 , R 3 , and R 6  are methyl. 
     
     
         9 . The method of  claim 1 , wherein R 4  is C(O)Me. 
     
     
         10 . The method of  claim 1 , wherein R 5  is ethyl. 
     
     
         11 . The method of  claim 1 , wherein R 7  is tert-butyldimethylsilyl. 
     
     
         12 . The method of  claim 1 , wherein R 8  is butyl. 
     
     
         13 . The method of  claim 1 , wherein R 9  is pentyl. 
     
     
         14 . The method of  claim 1 , wherein the compound of Formula I is: 
       
         
           
           
               
               
           
         
       
     
     
         15 . The method of  claim 1 , wherein the method does not produce more than about 1.0% of an isomer other than the compound of Formula I. 
     
     
         16 . The method of  claim 1 , wherein the method does not produce more than about 0.15% of an isomer other than the compound of Formula I. 
     
     
         17 . The method of  claim 1 , wherein the method does not produce more than about 0.1% of an isomer other than the compound of Formula I. 
     
     
         18 . The method of  claim 1 , wherein the method does not produce more than about 0.05% of an isomer other than the compound of Formula I. 
     
     
         19 . The method of  claim 1 , wherein the compound of Formula I is at least about 95% pure. 
     
     
         20 . The method of  claim 1 , wherein the compound of Formula I is at least about 99% pure. 
     
     
         21 . The method of  claim 1 , wherein the compound of Formula I is at least about 99.8% pure. 
     
     
         22 . The method of  claim 1 , wherein any individual impurity is present in an amount of less than about 0.15%. 
     
     
         23 . The method of  claim 1 , wherein any individual impurity is present in an amount of less than about 0.1%. 
     
     
         24 . The method of  claim 1 , wherein any individual impurity is present in an amount of less than about 0.05%. 
     
     
         25 . The method of  claim 1 , wherein the compound of Formula I is prepared in an overall yield of at least about 5%. 
     
     
         26 . The method of  claim 1 , wherein the compound of Formula I is prepared in an overall yield of at least about 10%. 
     
     
         27 . The method of  claim 1 , wherein the total amount of the impurities is in an amount of less than about 5.0%. 
     
     
         28 . The method of  claim 1 , wherein the total amount of the impurities is in an amount of less than about 1.0%. 
     
     
         29 . The method of  claim 1 , wherein the total amount of the impurities is in an amount of less than about 0.2%. 
     
     
         30 . The method of  claim 1 , wherein the impurity is selected from: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       and a combination thereof. 
     
     
         31 . The method of  claim 1 , wherein the impurity is selected from: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       and a combination thereof. 
     
     
         32 . The method of  claim 1 , wherein, Formula I is prepared without the use of chiral chromatography. 
     
     
         33 . The compound of  claim 14 , wherein, sodium 4-((1R,2R,3aS,8bS)-2-hydroxy-1-((3S,4S,E)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl)-2,3,3a,8b-tetrahydro-1H-cyclopenta[b]benzofuran-5-yl)butanoate is prepared without the use of chiral chromatography. 
     
     
         34 . A compound of the formula: 
       
         
           
           
               
               
           
         
         wherein 
         R 6  is C 1-6  alkyl; 
         R 7  is a hydroxy protecting group; and 
         X is halide. 
       
     
     
         35 . The compound of  claim 32 , wherein the compound is: 
       
         
           
           
               
               
           
         
       
     
     
         36 .- 37 . (canceled) 
     
     
         38 . A method of treating cytokine release syndrome (CRS) in a subject, the method comprising administering to the subject a composition comprising an effective amount of the compound of Formula I or a pharmaceutically acceptable salt thereof according to  claim 1 ; wherein the CRS is treated. 
     
     
         39 . (canceled)

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